Heart valve delivery system and method with rotational alignment

ABSTRACT

A delivery system for a transcatheter heart valve (THV) to a subject is provided, the delivery system includes a delivery catheter housing the THV therein; an elongated member for receiving the THV thereon and having an accessory extending from the distal portion thereof, the accessory comprising a plurality of components for alignment with commissures of the THV during delivery of the THV, and a rotational member connected to the elongated member to rotate the accessory and THV together to align with a native or bioprosthetic valve commissure or valve leaflet at a desired angle.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation of U.S. application Ser. No.16/944,818, filed Jul. 31, 2020 which is a Continuation of InternationalApplication No. PCT/US19/50231, filed Sep. 9, 2019 which claims priorityto U.S. Provisional Application 62/728,346, filed Sep. 7, 2018, theentirety of which are incorporated herein by reference.

FIELD

A method and apparatus configured for delivery and implantation of aprosthetic heart valve in a native or prosthetic heart valve.

BACKGROUND

Transcatheter heart valve (THV) replacement in failing native andbioprosthetic valves are becoming increasingly common. THV replacementof native and bioprosthetic aortic, mitral, tricuspid and pulmonicvalves has been successfully performed. Transcatheter aortic valvereplacement (TAVR) is becoming the preferred treatment in patients withsymptomatic severe aortic stenosis and results on comparing surgical vstranscatheter AVR in low risk patients will be available in 2019.Predicted market growth for TAVR to treat severe aortic stenosis issignificant. In younger, low risk patients, the long-term durability ofTAVR remains unknown, and a significant number of these patients have orwill develop significant coronary artery disease, requiring diagnosticand therapeutic interventions. One of the major difference betweensurgical aortic valve replacement and TAVR is, in surgery the valves arealways aligned to native commissures and hence mimic the physiologicalopening and closing and may influence durability and function. Earlyevidence has pointed to the fact that, commissural alignment may alsoinfluence function of the THV after TAVR. Further, coronary access afterTAVR is known to be more difficult than after surgical aortic valvereplacement. This is due to the presence of native aortic valveleaflets, the THV frame occupying the aortic root and in some patientsdue to presence of commissure in front of the coronary ostia. Publishedcase series have shown that coronary angiography and PCI after TAVR aremore challenging, requiring more radiation exposure and IV contrast. Inurgent or emergency situation such as acute myocardial infarction, theissue of timely coronary access after TAVR is critical to life anddeath. By aligning the THV commissures to the native commissures, thereis a likelihood that there will be better function but more importantlyeasier access to the coronary ostia. Currently, there is no predictableand consistent method of aligning the THV neo-commissures with thenative or bioprosthetic aortic valve commissures with help of a deliverysystem.

Methods have been developed to split the native or bioprosthetic aorticvalve leaflet to facilitate coronary reaccess or avoid coronaryobstruction during TAVR. However, if a THV commissure is placed facingthe coronary ostium, such a method would not be feasible. This speaks tothe importance of developing a device that can align the THV commissuresto native commissures.

A delivery system that can consistently deliver a THV to the native orbioprosthetic aortic valve with the neo-commissures aligned with thenative or bioprosthetic aortic valve commissures is needed, since itwould reduce the risk of neo-commisural tab interference with coronaryorifices, making coronary reaccess after TAVR less difficult.

The ability for a delivery system to deliver and help align a THV tonative or bioprosthetic valve extends beyond the aortic valve. Theability to deliver and deploy a THV in a native mitral valve withcalcification, bioprosthetic pulmonic, mitral and tricuspid valve withspecific angle of alignment between neo-commissures and bioprostheticvalve commissures may help improve THV frame expansion and anchoragainst the bioprosthesis. There may also be hemodynamic reasons ofaligning neo-commissures with native and bioprosthetic valve commissuresin a specific angle.

SUMMARY

A delivery system for a transcatheter heart valve (THV) to a subject isprovided, the delivery system includes a delivery catheter housing theTHV therein; an elongated member for receiving the THV thereon andhaving an accessory extending from the distal portion thereof, theaccessory comprising a plurality of components for alignment withcommissures of the THV during delivery of the THV, and a rotationalmember connected to the elongated member to rotate the accessory and THVtogether to align with a native or bioprosthetic valve commissure or avalve leaflet at a desired angle. In some embodiments, the THV isadapted for placement at the aortic valve, the mitral valve or thetricuspid valve.

In some embodiments, the components of the accessory include a pluralityof radially outwardly extending projections. The components are usefulto identify the THV neo-commissures or sinuses.

In some embodiments, the projections are disposed at a distal portion ofthe THV during delivery of the THV. In some embodiments, the projectionsare disposed at a distal portion of the THV during delivery of the THV.

In some embodiments, the components are atraumatic filamentousprojections. In some embodiments, the components are loop-shapedprojections. The components can include radiopaque components, e.g., toaid in identifying the orientation of the visible components and the THVunder fluoroscopy. They may also contain materials to be distinctivelyvisible on echocardiography to aid in THV rotational alignment anddeployment.

In some embodiments, the rotational member includes a rotational wheelpositioned on a proximal handle portion. In some embodiments, therotational member includes a thumb slide positioned on a proximal handleportion. The delivery system can further include a nose cone.

The accessory can be manipulated as a part of the delivery system orindependent from the rest of the delivery system. The components of theaccessory have the option of being projected outward at the distal endof the delivery system and retracted within. The accessory can undergorotation in synchrony with the THV to maintain alignment of the THVcommissures/sinuses with the accessory. The accessory with its visiblecomponents can also undergo translational movement in synchrony orindependently from the THV mounted on the delivery system.

Orientation of the accessory components relative to the THV afterdeployment is maintained to confirm the final THV neo-commissuralorientation relative to the native or bioprosthetic valve commissures.

BRIEF DESCRIPTION OF THE DRAWINGS AND FIGURES

FIG. 1 is a schematic illustrating various transcatheter approaches todeliver a prosthetic heart valve to the heart

FIG. 2A illustrates an exemplary embodiment of a device configured fordelivery and implantation of a prosthetic heart valve in a native orprosthetic heart valve.

FIG. 2B illustrates another exemplary embodiment of a device configuredfor delivery and implantation of a prosthetic heart valve in a native orprosthetic heart valve.

FIG. 3A illustrates an exemplary embodiment of an accessory for use withthe devices of FIGS. 2A and 2B.

FIG. 3B illustrates another exemplary embodiment of an accessory for usewith the devices of FIGS. 2A and 2B.

FIG. 3C illustrates a further exemplary embodiment of an accessory foruse with the devices of FIGS. 2A and 2B.

FIG. 3D is a view in partial section of the accessory of FIG. 3Apositioned with respect to native or prosthetic valve commissures of asubject in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 3E is a view in partial section of the accessory of FIG. 3Bpositioned with respect to native or prosthetic valve commissures of asubject in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 3F is a view in partial section of the accessory of FIG. 3Cpositioned with respect to the sinuses of the native or prosthetic valveof a subject in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 4A is side view of the device of FIG. 2A and/or 2B with portions ofthe accessory in substantial alignment with the commissural posts of theballoon expandable THV in accordance with an exemplary embodiment of thedisclosed subject matter.

FIG. 4B is side view of the device of FIG. 2A and/or 2B with portions ofthe accessory in substantial alignment with the commissural posts of theself-expanding or mechanically-expanding THV in accordance with anexemplary embodiment of the disclosed subject matter.

FIG. 4C is side view of the device of FIG. 2A and/or 2B with portions ofthe accessory substantially offset from the commissural posts of theballoon expandable THV in accordance with an exemplary embodiment of thedisclosed subject matter.

FIG. 4D is side view of the device of FIG. 2A and/or 2B with portions ofthe accessory substantially offset from the commissural posts of theself-expanding or mechanically-expanding THV in accordance with anexemplary embodiment of the disclosed subject matter.

FIG. 5A illustrates a further embodiment of the device of FIG. 2A.

FIG. 5B illustrates the embodiment of FIG. 5A with the THV partiallydeployed in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 6A is an embodiment of a rotation alignment structure of the devicein accordance with an exemplary embodiment of the disclosed subjectmatter.

FIG. 6B is another embodiment of a rotation alignment structure of thedevice in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 6C is a further embodiment of a rotation alignment structure of thedevice in accordance with an exemplary embodiment of the disclosedsubject matter.

FIG. 7A illustrates the device of FIG. 6A prior to deployment of the THVpositioned at the aortic root above the aortic valve annulus.

FIG. 7B illustrates the device of FIG. 6A prior to deployment of theTHV, such that the component is positioned through the aortic valveannulus.

FIG. 8A illustrates re-collapse of a portion of the accessory of thedevice to assist in repositioning of the THV in accordance with anexemplary embodiment of the disclosed subject matter.

FIG. 8B is a fluoroscopic view of the procedure of FIG. 8A in accordancewith an exemplary embodiment of the disclosed subject matter.

FIG. 9 illustrates the positioning of the device in accordance with anexemplary embodiment of the disclosed subject matter.

FIG. 10A is a fluoroscopic view illustrating the orientation of theaccessory after deployment of a balloon-expandable THV.

FIG. 10B is a fluoroscopic view illustrating the orientation of theaccessory after deployment of a self-expandable THV.

FIG. 11 illustrates the positioning of the device with respect to themedial commissure, the lateral commissure, the anterior annulus, and theposterior annulus of the mitral valve.

FIG. 12 illustrates the orientation of the THV and the accessory of FIG.5A to align with the commissures of the prosthetic heart valve.

FIG. 13A is a fluoroscopic visualization of the accessory duringtranscatheter heart valve positioning in native mitral valve.

FIG. 13B is a fluoroscopic visualization of the accessory aftertranscatheter heart valve deployment in transcatheter mitral valvereplacement in native mitral valve.

FIG. 14A is a fluoroscopic visualization of the accessory duringtranscatheter heart valve positioning in a prosthetic mitral valve.

FIG. 14B is a fluoroscopic visualization of the accessory aftertranscatheter heart valve deployment in transcatheter mitral valvereplacement in a prosthetic mitral valve.

DETAILED DESCRIPTION OF THE DISCLOSED SUBJECT MATTER

While methods, systems and devices are described herein by way ofexamples and embodiments, those skilled in the art recognize that themethods, systems and devices for delivery and implantation of aprosthetic heart valve in a patient are not limited to the embodimentsor drawings described. It should be understood that the drawings anddescription are not intended to be limited to the particular formdisclosed. Rather, the intention is to cover all modifications,equivalents and alternatives falling within the spirit and scope of theappended claims. Any headings used herein are for organizationalpurposes only and are not meant to limit the scope of the description orthe claims. As used herein, the word “may” is used in a permissive sense(i.e., meaning having the potential to) rather than the mandatory sense(i.e., meaning must). Similarly, the words “include,” “including,” and“includes” mean including, but not limited to.

The basic components of exemplary embodiments of a device for deliveryand implantation of a prosthetic heart valve in a patient are describedherein. As used in the description, the terms “top,” “bottom,” “above,”“below,” “over,” “under,” “above,” “beneath,” “on top,” “underneath,”“up,” “down,” “upper,” “lower,” “front,” “rear,” “back,” “forward,”“backward” and “left,” “right” refer to the objects referenced when inthe orientation illustrated in the drawings, which orientation is notnecessary for using the devices or achieving the methods describedherein. The term “proximal” as used herein is understood to refer to thelocation further away from the tip of the delivery catheter, proximal tothe transcatheter heart valve. The term “distal” as used herein isunderstood to refer to the location closest to the tip of the deliverycatheter.

Aortic

Exemplary embodiments for delivery and implantation of a prostheticaortic heart valve in a patient are described herein. The deliverysystem will be either retrograde (transfemoral, axillary/subclavian,transaortic, transcarotid, transcaval, suprasternal) or antegrade(transapical) (FIG. 1). The design principles of the delivery catheterand accessory are the same but the delivery system lengths will varybased on the approach.

An exemplary embodiment of the delivery system 100 is illustrated inFIG. 2A. The system 100 includes the valve delivery catheter 1. Asindicated by arrow 3, the delivery catheter 1 has rotational freedom.System 100 further includes accessory 6, delivery shaft 2 forcontrolling accessory 6, and nose cone 7 for passing over guide wire 8.The accessory 6, advanced to a position distally to the THV 4 near or atthe nose cone 7, may include three components, e.g., radially outwardlyextending symmetric projections 32.

In some embodiments, projections 32 are fabricated from Nitinol orsimilar material having elastic and/or shape memory characteristics.During deployment of the THV through the vascular system of the subject,the projections 32 can be compressed within the cone 7 to allowatraumatic passage of the accessory 6 to the valve location.Subsequently, the cone 7 is separately advanced distally to allow theprojections 32 to extend to the radially outward configuration of FIG.2A. In some embodiments, projections 32 can include radiopaquestructures or markers to facilitate alignment of the accessory 6, theTHV 4 and the subject's anatomy.

Accessory 6 is connected to shaft 2 that is adapted to independentlyadvance, rotate and retract accessory 6 within the delivery catheter 1.The rotational freedom of accessory 6 with respect to delivery catheter1 is illustrated by arrow 5. An advantage of system 100 is that if theTHV 4 needs to be recaptured and repositioned after complete deployment,and if recapturing and repositioning the device may lead to misalignmentbetween the THV commissures and the accessory components, the accessory6 can be manually rotated to re-align with the THV commissures toconfirm orientation relative to native or bioprosthetic valvecommissures.

Another exemplary embodiment of the system 200 is illustrated in FIG.2B, and is substantially identical to system 100, with the differencesnoted herein. The accessory 60 can be an integral part of the valvedelivery catheter 10, whereby proximal unsheathing of the THV willexpose the accessory 60 distal to the THV and hence the three visibleprojections 32. System 200 has the benefit of having a simpler deliverycatheter 10 having only one movable part (composite valve deliverycatheter 10 and accessory 60) instead of two separate independentlymovable parts.

The components of the accessory can take a variety of shapes andlengths. For example, the accessory can include soft filamentousprojections that are atraumatic to the native tissue (accessory 11illustrated in FIG. 3A and accessory 12 illustrated in FIG. 3B). In theexemplary embodiment shown in FIG. 3A, three components, e.g.,projections, are depicted. In the exemplary embodiment of FIG. 3B,accessory 12 includes three components, e.g., three pairs ofprojections. In some embodiments, the accessory can include“tear-drop”-shaped loops made of soft metallic composites that areflexible and atraumatic (accessory 13 illustrated in FIG. 3C). (Whileaccessory 11, 12 and 13 is illustrated extending from shaft 2 in FIGS.3A, 3B, 3C, it is understood that the configurations of accessory 11, 12and 13 are interchangeably used in systems 100 and 200 describedherein.)

In some embodiments, the projections are adjustable in length so thatthey can be extended/retracted as desired (not shown). In the exemplaryembodiments shown in FIGS. 3A, 3B and 3C, each projection is capable ofbeing moved independently. Furthermore, each projection can exhibit avariable radius of curvature such that the projections can bearticulated (or “curled”) to conform to a desired valve contour.

As illustrated in FIG. 3D, accessory 11 (illustrated in FIG. 3A) can bepositioned to align with native or prosthetic valve commissures C. Asillustrated in FIG. 3E, accessory 12 (illustrated in FIG. 3B) can bepositioned to straddle between each commissure C of the native orbioprosthetic aortic valve to aid in alignment with the THV commissure.As illustrated in FIG. 3F, accessory 13 (illustrated in FIG. 3C) can bepositioned above the sinuses of the native or prosthetic valve inalignment with the valve leaflets L.

The accessory components can include radiopaque parts to aid in accuratevisualization under fluoroscopy, and also include echogenic parts to aidin visualization under echocardiography. However, the accessorycomponents will not have parts that would visually or mechanicallyinterfere with visualization and accuracy of the THV deployment underfluoroscopy or echocardiography.

During the surgical procedure, the projections of the accessory 6 willbe either in a first “aligned” configuration, e.g., aligned with thecommissural posts 20 (illustrated with dotted lines) of the THV(illustrated in FIG. 4A with balloon expanding transcatheter heart valve4 and FIG. 4B with self-expanding or mechanically-expandingtranscatheter heart valve 40), or alternatively, in a second “offset”configuration, e.g., offset by, e.g., 60 degrees (illustrated in FIG. 4Cwith balloon expanding transcatheter heart valve 4 and FIG. 4D withself-expanding or mechanically-expanding transcatheter heart valve 40),at the base of sinus of transcatheter heart valve between twocommissural posts 20 (illustrated with dotted lines), prior to mountingand crimping onto the delivery catheter such that during valve deliveryand deployment the alignment will be maintained.

In some embodiments, the accessory 6 includes both a distal portionincluding distal projections 32 and a proximal portion 22 includingproximal projections 31, such that after the THV 4 is positioned ordeployed, the portion 22 of accessory 6 located proximal to the THV canbe used to confirm orientation (FIG. 5A-5B). The base of the sinus ofthe transcatheter heart valve 21 is illustrated in FIG. 5B.

In some embodiments, e.g., system 100 (FIG. 2A), the valve deliverycatheter 1 and the accessory 6, which can be independently manipulated,further include a locking and unlocking mechanism such that both partscan be locked together to maintain alignment between the accessorycomponents and the THV commissures 20 in both “aligned” configuration(FIGS. 4A-4B) and “offset” configuration (FIGS. 4C-4D). In someembodiments, the locking mechanism is located within the handle/housing26 (not shown).

In some embodiments, e.g., system 100 (FIG. 2B), because the valvedelivery catheter 10 and the accessory 60 are a single unit, the THVcommissures and the accessory components would be aligned at all times.

Alignment accessory control is provided. The delivery catheter 1 caninclude an independent mechanism to rotate the THV 4 and accessory 6 inunison to maintain the alignment between the components on the accessoryand the THV commissures 20 to optimize the alignment between THVcommissures 20 to the native or bioprosthetic aortic valve commissures,prior to valve implantation. This mechanism can include a turning wheelor knob 25 on the delivery system handle 26, such that one-to-onerotational alignment between the turning wheel 25 and the accessory 6(not shown) is possible to allow accurate orientation of the THVrelative to the native or bioprosthetic valve commissures or sinuses(FIG. 6A). FIG. 6B illustrates another embodiment of the knob 27 onsystem handle 26. Dotted arrows on FIGS. 6A and 6B illustrate rotationmovement of knobs 25, 27, respectively. FIG. 6C illustrates anotherembodiment including a translational slide 28 operative with a helicalscrew or other similar configuration on system handle 26 to providerotational alignment of the THV relative to the native or bioprostheticvalve commissures or sinuses. Solid arrows on FIG. 6C illustratetranslation movement of slide 28.

The manual rotational alignment between the THV 4 and the native orbioprosthetic aortic valve commissures can occur prior to THVpositioning across the native aortic annulus or bioprosthetic aorticvalve, or after the THV 4 is fully deployed if the THV can berepositioned or recaptured.

FIG. 7A illustrates the balloon-expandable transcatheter heart valve 4crimped prior to deployment. The accessory 6 is positioned at the aorticroot 29 (including sinuses 29A, 29B, 29C) above the aortic valve annulus30, such the projections 32 of accessory 6 are aligned with the nativeaortic valve commissures. The dashed line R illustrates rotationalalignment of the transcatheter heart valve 4 with the commissures.Proximal portion 22 of the accessory 6 includes corresponding outwardlyextending projections 31. Arrow D illustrates the direction of distaladvancement of the transcatheter heart valve 4 and the accessory 6across the annulus 30, resulting in the position of the transcatheterheart valve 4 and accessory 6 illustrated in FIG. 7B.

The case where the THV 4 would need to be partly or fully recapturedbefore rotational alignment can be performed, e.g., to avoid interactionwith the native or bioprosthetic aortic valve, is illustrated in FIGS.8A-8B. As illustrated in FIG. 8A, arrow R represents distal movement ofthe valve delivery catheter 1 recapturing aself-expanding/mechanically-expanding transcatheter heart valve 40 whichwill recollapse the proximal components 22 of the accessory 6 within thecatheter 1, resulting in the fluoroscopic view illustrated in FIG. 8B.

Additionally or alternatively, the alignment accessory control 2 canadjust the pitch and/or yaw of the THV 4/40 and/or accessory 6 to orientthe components to conform to the native commissures. In someembodiments, the THV 4/40 and/or accessory 6 can be rotated up to 360degrees; the pitch and yaw (measured relative to a longitudinal centralaxis of the THV) can be adjusted by up to 90 degrees.

In situations where the accessory components may straddle between eachaortic valve commissure or to the base of the aortic sinus after THVdeployment, the relative rotational misalignment between the accessorycomponents and THV commissures can be visualized and identified byrotational fluoroscopy. In this case, the THV can be recaptured andrepositioned for improved alignment with the native or bioprostheticvalve commissures, as visualized by the accessory components.

In balloon-expandable THV 4, the projections 32 of the accessory 6 maybe loaded through the top row of open cells of the THV frame, such thatthe projections 32 will be positioned equidistant (60 degrees) from thethree commissural posts. The projections 32 will be extended to positionat the base of the three aortic sinuses 29A, 29B, 29C during THVpositioning and deployment. FIG. 9 showing it can be mounted across theopen cells of a balloon expandable transcatheter heart valve such thateach component will be oriented and positioned above the base of thesinus prior to valve deployment.

After THV is deployed, these components of the accessory can bewithdrawn and retrieved via the THV delivery system through anindependent mechanism.

After the THV is deployed, the positions of the accessory componentsrelative to the THV commissures identified on fluoroscopy determine thefinal THV orientation relative to the native or bioprosthetic aorticvalve commissures. FIG. 10A illustrates the orientation of the accessory6 after deployment of balloon-expandable transcatheter heart valve 4.FIG. 10B illustrates the orientation of the accessory 6 after deploymentof self-expanding transcatheter heart valve 40.

The accessory components in system 100 may be manipulated and retractedafter the THV is deployed. In system 200, after the valve deliverycatheter is withdrawn from the THV, the accessory components can beresheathed over by the delivery catheter capsule to avoid interferencewith native issue to allow safe removal of the valve delivery system.

A cerebral embolic protection system may be mounted to the accessory toreduce stroke risk. In this version, the accessory components will spanthe diameter of the ascending aorta such that the cerebral embolicprotection system can be fully deployed. In this version, only theaccessory containing the cerebral embolic protection system will operateindependently from the valve delivery catheter (similar to theinteraction of catheter 1 and accessory 6 of system 100 describedherein).

Mitral

Exemplary embodiments for delivery and implantation of a prostheticmitral heart valve in a patient are described herein. The deliverysystem can be either an antegrade (transseptal, transatrial) orretrograde (transapical) approach to the mitral valve (FIG. 1). Thedesign principles of the delivery catheter and accessory are thesubstantially identical to the systems 100 and 200 described hereinabove; however, the delivery system lengths will vary based on theapproach.

According to a first mitral embodiment (substantially identical tosystem 100), the accessory 6, located distal (+/− proximal) to the THV,includes at least three symmetric projections 32 that include radiopaquestructures and a shaft to independently advance, rotate and retractwithin the delivery system. An advantage of this design is that if theTHV needs to be recaptured and repositioned after complete deployment,and if recapturing and repositioning the device may lead to misalignmentbetween the THV commissures and the accessory components, the accessorycan be manually rotated to re-align with the THV commissures to confirmorientation relative to native or bioprosthetic valve commissures.

According to a second mitral embodiment (substantially identical tosystem 200), the accessory 60, located distal (+/− proximal) to the THV,can be an integral part of the valve delivery catheter 10, wherebyproximal unsheathing of the THV during deployment will expose theaccessory 60 distal to the THV and hence at least the three visibleprojections 32. This concept has a benefit of having a simpler deliverycatheter with only one movable part (composite valve delivery catheterand accessory) instead of two separate independently movable parts.

As with the aortic accessory, the accessory components for the mitralapplication can take a variety of shapes, including soft and flexiblefilamentous projections that are atraumatic to the native tissue. Theaccessory components may be positioned to align with the commissures ofthe native mitral valve, center of posterior annulus, or bioprostheticvalve commissures, in addition to alignment with the THV commissures.The accessory components can include radiopaque parts to aid in accuratevisualization under fluoroscopy, and also can include echogenic parts toaid in visualization under echocardiography. However, the accessorycomponents will not have parts that would visually or mechanicallyinterfere with visualization and accuracy of the THV deployment underfluoroscopy or echocardiography.

The components on the accessory will be aligned with the commissuralposts of the THV prior to mounting and crimping onto the deliverycatheter such that during valve delivery and deployment the alignmentwill be maintained. In the first mitral embodiment, the valve deliverycatheter and the accessory, which can be independently manipulated,include a locking and unlocking mechanism such that both parts can belocked together to maintain alignment between the accessory componentsand the THV commissures. In the second mitral embodiment, because thevalve delivery catheter and the accessory for a single unit, the THVcommissures and the accessory components would be aligned at all times.

FIG. 11 illustrates the positioning of the system 100 with respect tothe medial commissure 33, the lateral commissure 34, the anteriorannulus 35, and the posterior annulus 36 of the mitral valve. Accessory6 includes projections 32 located distal to the transcatheter heartvalve 4, to be oriented to the medial and lateral commissures, and thedistal portion of the accessory 22 includes projections 31 locatedproximal to the transcatheter heart valve 4, to be oriented to themedial and lateral commissures. The projections 31 and 32 are oriented120 degrees apart from each other to aid in alignment of transcatheterheart valves with prosthetic heart valves. In some embodiments, oneprojection of the accessory 6 will always face the middle of theposterior mitral valve annulus 36.

FIG. 12 illustrates the orientation of the transcatheter heart valve 4in its crimped form, aided by the projections 31, 32 to align with thecommissures 20 of the prosthetic heart valve 37.

The delivery catheter includes an independent mechanism to rotate theTHV and accessory in unison to maintain the alignment between thecomponents on the accessory and the THV commissures to optimize thealignment between THV commissures to the native mitral valve commissuresand the center of posterior mitral annulus, or bioprosthetic mitralvalve commissural posts, prior to THV implantation. In some embodiments,this mechanism is a turning wheel or knob on the delivery system handle,such that one-to-one rotational alignment between the turning wheel andthe accessory is possible to allow accurate orientation of the THVrelative to the native commissures and center of the posterior annulusor bioprosthetic mitral valve commissures. (See, e.g., FIGS. 6A-6C).

The manual rotational alignment between the THV and the native orbioprosthetic mitral valve commissures can occur prior to or during THVpositioning across the native mitral annulus or bioprosthetic mitralvalve, or after the THV is fully deployed if the THV can be repositionedor recaptured (FIGS. 13A, 14A). In the latter case, the THV would needto be partly or fully recaptured before rotational alignment can beperformed to avoid THV interacting with the native or bioprostheticmitral valve.

In situations where the accessory components face the native mitralcommissures and center of posterior annulus, or the bioprosthetic mitralcommissures, after THV deployment, the relative rotational misalignmentbetween the accessory components and THV commissures can be visualizedand identified. In this case, the THV can be recaptured and repositionedfor improved alignment relative to the commissures, as visualized by theaccessory components.

After the THV is deployed, the positions of the accessory componentsrelative to the THV commissures identified on fluoroscopy determine thefinal THV orientation relative to the native or bioprosthetic mitralvalve commissures (FIG. 13B, 14B).

The accessory components in system 100 may be manipulated and retractedafter the THV is deployed. In system 200, after the valve deliverycatheter is withdrawn from the THV, the accessory components can beresheathed over by the delivery catheter capsule to avoid interferencewith native issue to allow safe removal of the valve delivery system.

Tricuspid

Exemplary embodiments for delivery and implantation of a prosthetictricuspid heart valve in a patient are described herein. The deliverysystem will be an antegrade (transfemoral, transjugular, transaxillary)approach to the tricuspid valve (FIG. 1). The design principles of thedelivery catheter and accessory are the same as for the mitral valve butthe accessory will consist of components based on the anatomy of thenative or bioprosthetic tricuspid valve.

Having described and illustrated the principles of our invention withreference to the described embodiments, it will be recognized that thedescribed embodiments can be modified in arrangement and detail withoutdeparting from such principles. It should be understood that thesystems, processes, or methods described herein are not related orlimited to any particular type of environment, unless indicatedotherwise.

In view of the many possible embodiments to which the principles of ourinvention can be applied, we claim as our invention all such embodimentsas can come within the scope and spirit of the following claims andequivalents thereto.

1.-28. (canceled)
 29. A medical device for delivery of a transcatheterheart valve (THV) to a subject, the device comprising: an elongatedmember; an accessory for receiving the THV thereon and extending from adistal portion of the elongated member, the accessory comprising aplurality of radially outwardly extending projections configured andspaced to align with a leaflet or a commissure of a native orbioprosthetic valve and disposed distally and spaced apart from the THVduring delivery of the THV for alignment of the THV with respect to anative or bioprosthetic valve commissure or a valve leaflet at a desiredangle during delivery of the THV and wherein the radially outwardlyextending projections are spaced apart from the valve implant, and arotational member connected to the elongated member to rotate theaccessory and THV together to align with the native or bioprostheticvalve commissure or the valve leaflet at a desired angle.
 30. Themedical device of claim 29, wherein the delivery catheter and theaccessory are independently rotatable.
 31. The medical device of claim29, further comprising projections disposed at a proximal portion of theTHV during delivery of the THV.
 32. The medical device of claim 31,wherein the projections extend radially outwardly from the elongatedmember.
 33. The medical device of claim 29, wherein the projections areatraumatic filamentous projections.
 34. The medical device of claim 29,wherein the projections are loop-shaped projections.
 35. The medicaldevice of claim 29, wherein the projections are configured to extendfrom the elongated member and retract within the elongated member. 36.The medical device of claim 29, wherein each projection is capable ofbeing moved independently.
 37. The medical device of claim 29, whereinthe delivery catheter, the elongated member and the THV are adapted fordeployment to the aortic valve of the subject, the mitral valve of thesubject, or the tricuspid valve of the subject.
 38. The medical deviceof claim 29, wherein the projections are capable of being compressedwithin a delivery catheter during delivery.
 39. The medical device ofclaim 29, further comprising a nose cone positioned distal of theaccessory.
 40. A method for delivery of a transcatheter heart valve(THV) to a subject comprising: providing an elongated member forreceiving the THV thereon and having an accessory extending from thedistal portion thereof, the accessory comprising a plurality of radiallyoutwardly extending projections disposed at a distal portion of the THVand spaced apart therefrom, the elongated member and accessory housedwithin and independently rotatable with respect to a delivery catheter;deploying the elongated member and THV from the delivery catheter at thenative valve location; rotating the accessory to align the THV withrespect to a native or bioprosthetic valve commissure or a valve leafletat a desired angle; and expanding the THV in the valve location.
 41. Themethod of claim 40, further comprising, prior to deploying the elongatedmember, compressing the projections within the delivery catheter into acompressed configuration.
 42. The method of claim 40, furthercomprising, after compressing the projections, advancing the projectionsto expand to a radially outward configuration.
 43. The method of claim40, wherein the valve location is the aortic valve, the mitral valve, orthe tricuspid valve.
 44. The method of claim 40, wherein rotating theaccessory comprises rotating the accessory to align the radiallyoutwardly extending projections with the native or bioprosthetic valvecommissure.
 45. The method of claim 40, wherein rotating the accessorycomprises rotating the accessory such that the radially outwardlyextending projections straddle the native or bioprosthetic valvecommissure.
 46. The method of claim 40, further comprising extending theprojections from the elongated member.
 47. The method of claim 40,further comprising retracting the projections into the elongated member.48. The medical device of claim 40, further comprising providing a nosecone positioned distal of the accessory